N.Y.U. Langone withdraws from type 1 diabetes vaccine trial in adolescents

The B.C.G. vaccine, more than a century old, has shown promise against diabetes. The university's decision left parents and outside investigators concerned.

N.Y.U. Langone Health withdrew from a trial of using an old tuberculosis vaccine to treat children with type 1 diabetes just months after it began recruiting participants on Long Island.

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The vaccine, called Bacillus-Calmette-Guerin, or B.C.G., has generated strong interest among various patient advocacy groups, including those focused on Alzheimer's disease and cancer, as well as diabetes. Some recent research suggests the vaccine, first given in 1921, may also protect against Covid-19 and respiratory disease due to its widespread effects on the immune system.

A large trial of the effects of the vaccine on blood sugar levels in adults with type 1 diabetes is nearing completion. Scientists had hoped to test the B.C.G. vaccines on children as well, because good management of type 1 diabetes leads to fewer diabetes-related complications.

The pediatric trial's principal investigators, who are Massachusetts General Hospital in Boston are continuing the study, but N.Y.U. Langone's abrupt withdrawal could potentially jeopardize his viability if they are unable to collect data on the children of the N.Y.U. site.

A total of 150 children were to be included in the study, and the N.Y.U. team had already administered the vaccine to at least 18 young people. They were to be followed for five years; each was to receive eight security screening visits in the first year following their inoculations.

"Who is medically monitoring our daughter now, and who is monitoring the injection site ? said Kevin Miller of Smithtown, N.Y., whose 14-year-old daughter enrolled in the study last year.

"I'm sure there's something in the fine print of all the papers we've signed that say they have the legal right to do it," Miller added, "but I don't necessarily know that means he is right to let kids like my daughter and others hang around.p>

N.Y.U. Langone officials said in a statement that an institutional review board, which approved study in December 2020, decided to end participation after reviewing more research on the B.C.G. vaccine.

A statement says the university "has determined that withdrawal from the study will not affect the safety of enrolled participants," and said children could continue to see N.Y.U. physicians for their care. common causes of diabetes.

An earlier study by Massachusetts General scientists found that two doses of B.C.G. the vaccine reduced blood sugar levels to near normal levels in a very small group of adults with type 1 diabetes. Other B.C.G. studies, using different versions of the vaccine and following subjects with type 1 diabetes for variable periods of time, gave mixed results.

The new trial is phase II, aimed at evaluating the effectiveness of the vaccine treatment. Usually, when such trials are stopped, it is for security reasons. Enrollment of new participants ceases, but subjects who have already received the intervention continue to be followed.

N.Y.U. however, made no mention of a safety issue and will no longer follow the participants for the purposes of the study.

The principal investigator of the trial , Dr. Denise Faustman, director of the immunobiology laboratory at Massachusetts General Hospital, said the withdrawal of N.Y.U. was a serious deviation from the trial protocol that could jeopardize the final results.

"The Food and Drug Administration cares most about the safety of children and child protection, and missing a safety visit is a serious breach of protocol,” she said.

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